Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years

NCT03635268 | Completed

• 1 other identifier: MARIET AOI 2017
• Study Type: observational
• Target: 360,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intravitreal injections (IVI) of antiangiogenic agents (AA) have revolutionized the management of age-related macular degeneration (AMD) and diabetic macular edema (DME) in particular. Approximately 600,000 AA IVIs are performed each year in France. Corticosteroid IVIs are an alternative in the treatment of macular edema when it is diabetic or related to venous occlusion, but also due to inflammation. Endophthalmitis is one of the most feared complications after IVI because of its poor prognosis, despite its low incidence (values found in the literature between 0.01% and 0.08%). IVI practices have evolved over the years based on the recommendations of specialized organizations, with the current recommendation not to use antibiotic prophylaxis. The purpose of this study is to study the effect of intravitreal injections of anti-angiogenic agents and corticosteroids on the occurrence of endophthalmitis within 28 days following an injection.

Conditions

Intravitreal Injection

Outcome Measures

Primary Outcomes (1)

• Frequency of occurrence of endophthalmitis

  Up to 28 days following an intravitreal injection

Interventions

Data collection OTHER

Sociodemographic, medical and hospital, on ambulatory care consumption data.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who has had an intravitreal injection to deliver an anti-angiogenic agent or a corticosteroid

You may qualify if:

• adult patients within the French population who had an intravitreal injection, identified by CCAM coding BGLB001
• associated with the delivery of an anti-angiogenic agent or a corticosteroid, identified by the corresponding CIP code
• between February 2007 and November 2015

You may not qualify if:

• intraocular surgery less than 42 days before the first injection, identified by the CCAM procedure
• risk factors for endogenous endophthalmitis identified in the 42 days preceding an IVI identified by the ICD10 code

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Related Publications (1)

• Baudin F, Benzenine E, Mariet AS, Bron AM, Daien V, Korobelnik JF, Quantin C, Creuzot-Garcher C. Association of Acute Endophthalmitis With Intravitreal Injections of Corticosteroids or Anti-Vascular Growth Factor Agents in a Nationwide Study in France. JAMA Ophthalmol. 2018 Dec 1;136(12):1352-1358. doi: 10.1001/jamaophthalmol.2018.3939.

  PMID: 30242325 RESULT

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: February 9, 2026

Record last verified: 2026-02